PR92219

TOKYO, Oct. 12, 2021 /PRNewswire=KYODO JBN/ --

- Agreement to accelerate the development and commercialization of odevixibat

in Japan, a significant market for PFIC, Alagille syndrome and biliary atresia

- Bylvay™ (odevixibat) approved in U.S., EU and UK with global prescriptions

already generated

- CBC continues its momentum to address significant unmet medical needs in Asia

Jadeite Medicines Inc. ("Jadeite"), a biopharmaceutical company that is backed

by Singapore's CBC Group ("CBC") and committed to addressing critical unmet

medical needs for patients in Japan, today entered into an exclusive licensing

agreement with Albireo Pharma, Inc. (Nasdaq: ALBO) for the development and

commercialization of odevixibat in Japan for progressive familial intrahepatic

cholestasis (PFIC), Alagille syndrome (ALGS) and biliary atresia.

Under the terms of the agreement, Albireo will receive an upfront payment of

US$15 million and will be eligible to receive up to US$120 million in milestone

payments, as well as double-digit royalties. Jadeite will be responsible for

clinical development, regulatory approval and commercialization of odevixibat

in Japan, where there is significant market opportunity. Jadeite is backed by

CBC( http://www.cbridgecap.com/ ), which partners with the world's top

entrepreneurs and scientists and leverages its unique "investor-operator"

approach to empower global leading healthcare companies to widen access to

affordable medical care, catalyze innovations and improve efficiency in

fulfilling unmet medical needs worldwide.

"We are excited to partner with Albireo to accelerate delivery of odevixibat to

children living with rare liver diseases, initially targeting PFIC, followed by

potentially biliary atresia and Alagille syndrome, which all represent

significant unmet medical needs in Japan," said Eiichi Takahashi, M.D., Ph.D.,

Chief Executive Officer of Jadeite Medicines. "This agreement reinforces

Jadeite's commitment and vision to develop highly differentiated and innovative

medicines to improve the health and quality of life of patients in Japan."

"This agreement exemplifies Albireo's commitment to providing global

availability of Bylvay, particularly in areas like Japan where high prevalence

translates to a sizable number of patients who currently have no approved

treatment option. Jadeite's entrepreneurial, biotech approach makes them the

right type of partner to successfully commercialize Bylvay in Japan," said Ron

Cooper, President and Chief Executive Officer of Albireo. "The agreement allows

for success of both companies, and we look forward to further collaboration

with Jadeite."

Bylvay is the first drug approved in Europe for the treatment of all types of

PFIC and in the U.S. for the treatment of pruritus in all types of PFIC. A

potent, non-systemic ileal bile acid transport inhibitor (IBATi), Bylvay is

administered as a once-daily capsule or opened and sprinkled onto soft foods.

Bylvay is currently being evaluated in the ASSERT Phase 3 study for Alagille

syndrome, the BOLD Phase 3 study for patients with biliary atresia and the

ongoing PEDFIC 2 open-label trial for patients with PFIC.

"CBC remains steadfast in our commitment to widening access to medical care

globally, and Jadeite is our cornerstone in Japan. The partnership with Albireo

represents important progress toward that goal by expanding more treatment

options, initially for children living with rare liver diseases in Japan," said

Sean Cao, Ph.D., Managing Director of CBC Group. "By leveraging our extensive

investor-operator experience in Asia, we will continue to partner with the

world's top pharmaceutical companies and scientists and identify opportunities

to broaden global reach for patients with unmet medical needs."

CBC, founded in 2014, is Asia's largest healthcare-dedicated investment firm,

with US$4.6 billion AUM. Its portfolio has gained momentum in recent years by

incubating cutting-edge biopharmaceutical companies in Asia and beyond. Jadeite

is the first company to be incubated by CBC in Japan, following the success of

its unique investor-operator approached in empowering Nasdaq-listed I-Mab

Biopharma and Hong Kong-listed Everest Medicines.

About Bylvay (odevixibat)

Bylvay is the first drug approved in the U.S. for the treatment of pruritus in

patients 3 months of age and older in all types of progressive familial

intrahepatic cholestasis (PFIC). The European Commission (EC) and UK Medicines

and Healthcare Products Regulatory Agency (MHRA) have also granted marketing

authorization of Bylvay for the treatment of PFIC in patients aged 6 months or

older. Bylvay is available for sale in Germany and will be available for sale

in other European countries following pricing and reimbursement approval. A

potent, once-daily, non-systemic ileal bile acid transport inhibitor, Bylvay

acts locally in the small intestine. Bylvay can be taken as a capsule for older

children, or opened and sprinkled onto food, which are factors of key

importance for adherence in a pediatric patient population. The medicine can

only be obtained with a prescription and treatment should be started and

supervised by a doctor who has experience in the management of PFIC. For more

information about using Bylvay, see the package leaflet or contact your doctor

or pharmacist. For full prescribing information, visit www.bylvay.com.

In the U.S. and Europe, Bylvay has orphan exclusivity for its approved PFIC

indications, and orphan designations for the treatment of Alagille syndrome,

biliary atresia and primary biliary cholangitis. Bylvay is being evaluated in

the ongoing PEDFIC 2 open-label trial in patients with PFIC, in the BOLD Phase

3 study for patients with biliary atresia and in the ASSERT Phase 3 study for

Alagille syndrome.

About Albireo

Albireo Pharma is a rare disease company focused on the development of novel

bile acid modulators to treat rare pediatric and adult liver diseases.

Albireo's lead product, Bylvay, was approved by the U.S. FDA as the first drug

for the treatment of pruritus in all types of progressive familial intrahepatic

cholestasis (PFIC), and it is also being developed to treat other rare

pediatric cholestatic liver diseases with Phase 3 trials in Alagille syndrome

and biliary atresia, as well as an open-label extension (OLE) study for PFIC.

In Europe, Bylvay has been approved for the treatment of PFIC and has been

submitted for pricing and reimbursement approval. The Company has also

initiated a Phase 1 clinical trial for A3907 to advance development in adult

cholestatic liver disease, with IND-enabling studies of A2342 moving ahead for

viral and cholestatic liver disease. Albireo was spun out from AstraZeneca in

2008 and is headquartered in Boston, Massachusetts, with its key operating

subsidiary in Gothenburg, Sweden. The Boston Business Journal named Albireo one

of the 2020 Best Places to Work in Massachusetts for the second consecutive

year. For more information on Albireo, please visit www.albireopharma.com.

About Jadeite

Jadeite Medicines is a biopharmaceutical company focused on developing and

commercializing innovative pharmaceutical products that address critical unmet

medical needs for patients in Japan. The management team of Jadeite Medicines

has an extensive track record of high-quality clinical development and deep

expertise in regulatory affairs, CMC, business development and operations, both

in Japan and with leading global pharmaceutical companies. Jadeite Medicines

plans to build a portfolio of global first-in-class or best-in-class molecules,

many of which are in late-stage clinical development. For more information,

please visit www.jadeitemedicines.co.jp.

About CBC

CBC Group, Asia's largest healthcare-dedicated investment firm, is committed to

creating value and integrating global resources. Partnering with the world's

top entrepreneurs and scientists, its unique "investor-operator" approach has

empowered global leading healthcare companies to widen access to affordable

medical care, catalyze innovations, and improve efficiency in fulfilling unmet

medical needs worldwide. Founded in 2014, CBC has a leading team of investment,

industry and portfolio management professionals headquartered in Singapore with

offices in Shanghai, Beijing, Hong Kong and New York, and presences in Boston,

San Diego, San Francisco, and Tokyo. CBC focuses on platform-building, buyout,

credit and growth-focused opportunities across multiple core

areas within the healthcare sector, including pharmaceutical and biotech,

medical technology and healthcare services. For more information, please visit

www.cbridgecap.com.

SOURCE  CBC Group